Diabetic foot ulcer
Conditions
Interventions
Experimental group:test drug
Control group:placebo
Sponsors
Beijing You'an Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-45 (including the critical value), no gender limit. 2. Body mass index (BMI) is in the range of 19.0-28.0 (including critical value) (BMI=weight (kg)/height^2 (m^2)), male weight should be >= 50.0kg, and female weight should be >= 45.0kg. 3. The vital signs, physical examination, laboratory examination and related examinations during the screening period and baseline period were all normal or abnormal without clinical significance. 4. Those who have no reproductive plan within 2 weeks before screening and within 3 months after the end of the trial and agree to take effective non-drug contraceptive measures during this period. 5. Understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution, with a history of drug or food allergy, especially those who are allergic to this product and any ingredients in the excipients; 2. Those with any skin disease; 3. There are large tattoos, birthmarks, skin scars, skin perforations, etc. in the target application area, or the skin is thin, with ulceration, injury, sunburn, redness, rash, or abnormal fever; 4. Those with a history of smoking within 12 months before screening (number of cigarettes smoked per day >= 5); 5. Those with a history of alcoholism within 12 months before screening (drinking >=14 units of alcohol per week: 1 unit = 285ml of beer, or 25ml of spirits, or 150ml of wine) or those with positive alcohol breath test before enrollment; 6. Those who have a history of drug abuse within 12 months before screening or those who tested positive for addictive substances before enrollment; 7. Those who have a history of chronic diseases or serious diseases of cardiovascular, cerebrovascular, liver, kidney, lung, digestive tract, nerve, autoimmunity, metabolism and musculoskeletal system in the past; 8. Difficulty in venous blood collection and/or fainting of blood or needles; 9. Those who have had any back skin medication within 14 days before screening or within the 5 half-life of the drug (whichever is the longest); 10. Those who have participated in other clinical trials within 3 months before screening; 11. Those who have lost blood or donated blood >= 200mL within 8 weeks before screening; 12. Those who have a history of cancer in the past; 13. Pregnant and lactating patients; 14. Those who are considered inappropriate by the investigator to enter this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;tolerability; | — |
Countries
China
Contacts
Public ContactYu Haibin
Outcome results
None listed